Essential Medical has successfully completed additional clinical studies using its Manta 14F large bore vascular closure device, a vascular closure device designed to seal both 14F and 18F large bore femoral punctures.
Manta 14F devices were successfully deployed in four patients, achieving immediate or rapid haemostasis following 14F balloon aortic valvuloplasty cases with “excellent” clinical, angiographic and haemodynamic (Duplex Ultrasound) results, said a company press release. All patients were successfully discharged the following day. The Manta devices were deployed in less than one minute, without pain or discomfort for the patients.
Manta closes femoral arterial punctures made during cardiac catheterisation procedures such as transcatheter aortic valve replacement, balloon aortic valvuloplasty, and the endovascular treatment of abdominal aortic aneurysms. Manta utilises novel closure mechanics and can be deployed in less than 60 seconds with sealing components similar to the company’s other closure device, X-Seal. The potential worldwide market for vascular closure products is approximately US$1bn.
Gary Roubin, Essential Medical chief medical officer, commented on this most recent experience; “The deployment of the devices was excellent. This [study] provides critical information on the application and utility of these valuable additions to the interventional cardiologists toolkit.”
Large bore femoral access has been associated with significant morbidity including bleeding complications, the need for transfusions, increased hospital costs, patient discomfort and disability. Essential Medical believes that the Manta device has the potential to address all the aforementioned problems. “This series, together with our successful patients with Manta 18F last November, provides the necessary confidence to proceed to a EU CE-marking study including both Manta sizes,” commented Greg Walters, chief executive officer. “We expect to enrol patients early this summer at sites in Vancouver, Rotterdam, Amsterdam and Milan.”
The company has also enrolled the first patients in a post-market study in Germany utilising its X-Seal small-bore closure devices. The company is conducting a 50-patient study as a requirement for X-Seal CE mark approval that was received in October 2014. Commercialisation of X-Seal is expected through a strategic partner once the study is complete.